Plenum® Osshp in Maxillary Sinus Elevation Surgery

November 14, 2023 updated by: M3 Health

Double-blind Randomized Controlled Clinical Study of the Predictability of Using Plenum® Osshp in Maxillary Sinus Elevation Surgery

The aim of this study is to qualitatively and quantitatively evaluate bone neoformation in maxillary sinus lift surgery filled with Plenum® Oss hp, compared to filling with autogenous bone, and to verify the association of Plenum® Osshp with i-PRF (i-PR - injectable platelet-rich fibrin). For this, forty (40) participants will be recruited, divided into 4 groups, which will have 10 participants each, namely: Group 1: Autogenous bone; Group 2: Plenum® Osshp; Group 3: Plenum® Osshp; + i-PRF and Group 4: Plenum® Osshp; + autogenous bone. To evaluate the primary outcome, volumetric analysis will be performed by obtaining computed tomography scans at 15 days (T1) and 6 months (T2) after graft surgery, with the aid of a volumetric tomography machine for dentofacial images. The values obtained at T2 will be subtracted from those obtained from T1 to obtain the volumetric stability value. After six months of repair, biopsies will be performed using a trephine drill, followed by the installation of implants and healers. Through microcomputed tomography analysis, the parameters of bone volume fraction (BV/TV), total porosity (Po.Tot), trabecular thickness (Tb.Th), number of trabeculae (Tb.N) and separation of trabeculae (Tb.Sp) will be evaluated. Histomorphometric analysis will be performed to obtain the areas of bone neoformation, connective tissue and remaining biomaterial that will be calculated for each area of the sample (cervical, intermediate, and apical) and later summed, obtaining the total representative area of the sample. Through immunohistochemical analysis, specific primary antibodies to Runx2, VEGF, Osteocalcin (OC) and Tartrate-Resistant Acid Phosphatase (TRAP) will be identified. The occurrence of adverse events will be collected through the analysis of pain, infection, and edema. The quantitative results of the histomorphometric, microtomographic, and volumetric stability analysis will be tabulated and submitted to the ANOVA test, and if they present a statistically significant difference, it will be followed by the Tukey test (post hoc). A significance level of p<0.05 will be adopted for all tests.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • Sao Paulo
      • Araraquara, Sao Paulo, Brazil, 14800900
        • Recruiting
        • Universidade Estadual Paulista - UNESP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with alveolar ridge atrophy, with bone remnant less than 5 mm in height, with adequate bone volume in the ramus and/or symphysis region;
  • Over 18 years old;
  • And that they have signed the informed consent form.

Exclusion Criteria:

  • Smokers;
  • Patients with uncontrolled systemic diseases;
  • Patients with blood dyscrasias;
  • Patients with sinus pathologies;
  • Patients who take or have used medications that interfere with bone turnover;
  • Patients irradiated in the head and neck region;
  • Pregnant patients;
  • Patients with untreated periodontal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1: Autogenous bone graft
The maxillary sinus will treated with autogenous bone graft.
Procedure: Group 1: Autogenous bone graft
The maxillary sinus will be grafted with the autogenous bone graft.
Other Names:
  • Maxillary sinus elevation surgery
  • Maxillary sinus augmentation
  • Maxillary sinus lift
Experimental: Group 2: Plenum® Osshp
The maxillary sinus will treated with Plenum® Osshp.
Procedure: Group 2: Plenum® Osshp
The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device.
Other Names:
  • Maxillary sinus elevation surgery
  • Maxillary sinus augmentation
  • Maxillary sinus lift
Experimental: Group 3: Plenum® Osshp; + i-PRF
The maxillary sinus will treated with Plenum® Osshp associated with i-PRF (i-PR - injectable platelet-rich fibrin).
Procedure: Group 3: Plenum® Osshp; + i-PRF
The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with i-PRF.
Other Names:
  • Maxillary sinus elevation surgery
  • Maxillary sinus augmentation
  • Maxillary sinus lift
Experimental: Group 4: Plenum® Osshp + autogenous bone graft
The maxillary sinus will treated with Plenum® Osshp associated with autogenous bone graft.
Procedure: Group 4: Plenum® Osshp + autogenous bone graft
The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with autogenous bone graft.
Other Names:
  • Maxillary sinus elevation surgery
  • Maxillary sinus augmentation
  • Maxillary sinus lift

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of the maintenance of volume in the maxillary sinus region.
Time Frame: Fifteen days (T1) and six months (T2) from postoperative.
Computed tomography scans were performed and compared after graft surgery (T1) and after 6 months of repair (T2). The maintenance of the volume will be defined by the difference in the area of T2-T1.
Fifteen days (T1) and six months (T2) from postoperative.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of the bone neoformation of the synthetic graft in comparison with the autogenous graft and in association with i-PRF.
Time Frame: Six months from postoperative.
Microcomputed tomography analysis using the following variables: Bone volume fraction, total porosity, trabecular thickness, number of trabeculae and separation of trabeculae.
Six months from postoperative.
Rate of the areas of bone neoformation, connective tissue and remnant synthetic graft.
Time Frame: Six months from postoperative.
Histomorphometric analysis of the experimental groups.
Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time Frame: Six months from postoperative.
Quantification of specific marker for Runx2.
Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time Frame: Six months from postoperative.
Quantification of specific marker for VEGF.
Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time Frame: Six months from postoperative.
Quantification of specific marker for Osteocalcin (OC)
Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time Frame: Six months from postoperative.
Quantification of specific marker for Tartrate-Resistant Acid Phosphatase (TRAP).
Six months from postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M3 Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sybele Specian, PhD, Plenum (M3 Health)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Plenum Oss 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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